RECRUITING

Q Therapeutic System for Chronic Stroke Recovery

Conditions

Stroke Hemorrhage Brain Injury Cerebrovascular Accident (CVA)Chronic Stroke Patient BrainQ Cerebrovascular Disorders Electromagnetic Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.

Official Title

Facilitation Recovery For Patients With Chronic Stroke: The Q Therapeutic System, Frequency-Tuned Electromagnetic Field Treatment

Quick Facts

Study Start:2025-05-26

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06979466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* FMA-UE score between 22-50 (inclusive) of impaired limb. * Difference between Screening and Baseline visit FMA-UE is 3 points or fewer. * Age 18 to 80 years of age (inclusive). * Stroke due to ischemia or to intracerebral hemorrhage. * \>6 months to 5 years from index stroke onset. * Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit. * Able to sit with the investigational System for 40 consecutive minutes. * Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent. * Willingness to participate in physical exercises during study intervention sessions. * Availability of a relative or other caregiver able to assist during study treatment sessions and visits. * If female, not pregnant or breastfeeding or planning pregnancy during the study period. * Informed consent signed by subject.	* Severe neglect impairment interfering with assessments or treatments. * Severe depression, defined as GDS Score \>10/15 * The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator). * Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years * Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit * Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis * Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation. * Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation. * Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months. * Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial. * Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur. * Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit. * Employee of the Sponsor. * Prisoner.

Inclusion Criteria

Exclusion Criteria

* FMA-UE score between 22-50 (inclusive) of impaired limb.
* Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.
* Age 18 to 80 years of age (inclusive).
* Stroke due to ischemia or to intracerebral hemorrhage.
* \>6 months to 5 years from index stroke onset.
* Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
* Able to sit with the investigational System for 40 consecutive minutes.
* Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent.
* Willingness to participate in physical exercises during study intervention sessions.
* Availability of a relative or other caregiver able to assist during study treatment sessions and visits.
* If female, not pregnant or breastfeeding or planning pregnancy during the study period.
* Informed consent signed by subject.

* Severe neglect impairment interfering with assessments or treatments.
* Severe depression, defined as GDS Score \>10/15
* The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
* Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years
* Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
* Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
* Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
* Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
* Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
* Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
* Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur.
* Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
* Employee of the Sponsor.
* Prisoner.

Contacts and Locations

Study Contact

Josette Hartnett, MPH

CONTACT

9145972367

johartnett@burke.org

Andrew Abdou, DO

CONTACT

7327137373

aabdou@montefiore.org

Study Locations (Sites)

Burke Rehabilitation Hospital

White Plains, New York, 10605

United States

Collaborators and Investigators

Sponsor: Burke Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-26

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-05-26

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

BrainQ
Stroke
Cerebrovascular Disorders
Electromagnetic Stimulation

Additional Relevant MeSH Terms

Stroke
Hemorrhage
Brain Injury
Cerebrovascular Accident (CVA)
Chronic Stroke Patient